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- **DM Market Leader**: Brepocitinib Phase III data positions as first novel oral DM therapy with 30mg dose showing 1/3 patients off steroids. NDA filing Q1 2026.
- **Graves’ Innovation**: Batoclimab delivers 6-month remission in 81% of patients, with 75% off/low ATD use. FcRn mechanism validated by argenx’s VYVGART follow-on.
- **Litigation Catalyst**: Moderna trial March 2026; favorable Pfizer ruling. Global LNP enforcement could unlock $5B+ damages.
- **Pipeline Expansion**: 11 registrational trials across 6 indications. Sjögren’s Phase II targeting ESSDAI; Pulmovant PH-ILD data H2 2026.
- **Capital Strength**: $4.4B cash to fund pipeline through profitability; $500M buyback authorization.


**【CEO Summary Section】**
- **Brepocitinib Phase III Success**: VALOR trial in dermatomyositis (DM) met all endpoints with 30mg dose showing rapid, deep responses across muscle and skin metrics. 1/3 of patients achieved TIS40 and minimal/no steroid use at week 52. NDA filing for DM expected Q1 2026.
- **Graves' Disease Breakthrough**: Batoclimab showed durable remission in 17/21 patients off therapy for 6 months, with 75% off/low ATD use. Data supports disease-modifying potential via deep IgG suppression.
- **Financial Strength**: $4.4B cash, no debt. Strong pipeline with 11 registrational trials across DM, Graves', MG, CIDP, Sjögren’s, and RA.
- **Litigation Progress**: Favorable ruling in Pfizer case; Moderna trial set for March 2026. International cases progressing in UPC, Canada, Japan.
- **Upcoming Events**: Investor Day on Dec 11, 2025 to detail commercial strategy and pipeline updates.

**【Q&A Key Highlights】**
- **Competitive Landscape**: Argenx’s VYVGART in Graves’ validates FcRn strategy. Roivant’s higher IgG reduction (≥70%) in Phase II linked to better ATD discontinuation rates. FcRn safety/tolerability优势 in Graves’ seen as key differentiator.
- **Sjögren’s & Other Indications**: IMVT-1402 Phase II in Sjögren’s targeting ESSDAI; potential first-in-class with deeper IgG suppression. Pulmovant’s mosli for PH-ILD Phase IIb data expected H2 2026.
- **LNP Litigation**: Moderna U.S. sales <50% of global; 1498 patent defense scope narrow. International trials could yield decisions in 2026.
- **DM Launch Strategy**: No direct analogs; focus on unmet need in DM with oral, scalable therapy. Global enrollment in NIU trial progressing.
- **Ted Study**: Delayed data release to align with evolving competitive landscape. Focus on Graves’ as upstream opportunity.


Immunovant, Inc. (IMVT) Q2 2026 Earnings Call Transcript

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